ao 55 1988

Republic off the Philippines Department of Health OFFICE OF THE SECRETARY Manila December 7, 1988

ADMINISTRATIVE ORDER No. 55 s. 1988 SUBJECT:

REQUIREMENTS FOR LABELLING PHARMACEUTICAL PRODUCTS

MATERIALS

OF

SUMMARY: In pursuant to the "Foods, Drugs and Devices, and Cosmetics Act" and the "Generics Acts of 1998", it is required that the generic name shall be the one with the highest point size among the printed elements of the label, printed in full and enclosed exclusively by an outlined box. If the product is identified by a brand name shall be one point size bigger but in the same typeface, font and color as the brand name and shall appear immediately above the latter. Pursuant to R.A No. 3720 as amended by Executive order No. 175, otherwise known as the "Foods, Drugs and devices, and Cosmetic Act", and R.A No 6675, otherwise known as the "Generic Act of 1988", the following requirements for the labelling of pharmaceutical products are hereby promulgated of the information, guidance and compliance of all concerned; Section 1. Definition of Terms For purposes of this regulation the terms 1.1. "Labelling materials" includes the label on the immediate container, and the other printed materials that are made available with the product at the time of purchase and/or where the product is used, such as the outer wrapper cartons, leaflet/package insert accompanying the product, which provide the accurate and necessary detailed information for the identification and proper used of the product. 1.2. "Product" refers to pharmaceutical products which mean any pharmaceutical or biological product intended for used in the diagnosis, cure mitigation, treatment or prevention of disease in human, or to affect the structure or any function of the human body. 1.3. "Brand Name" refers to the proprietary/trade name assign to the product by the drug establishment. 1.4. "Generic Name" refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients determined by the Bureau of Food and Drugs of the DOH. 1.5. "Pharmacologic category" refers to the classification of the product based on its therapeutic action as specified in the product registration.

1.6. "Formulation" refers to the name (s) and amount (s) of active medicinal ingredients per dosage unit expressed in the metric system. 1.7. "Indication" refers to the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form. 1.8. "Dosage Form" means the pharmaceutical form of the preparation based on official pharmacopoeia. 1.9. "Mode of administration" refers to the site and manner the product is to be introduced in to or applied on the body. 1.10. "Warnings" refers to statements regarding the occurrence of potential hazards and side effects associated with the use of the product and the limitation of its use. 1.11. "Contraindications" refers to statements regarding the conditions wherein the use of the product may cause harm to the patient. 1.12. "Precautions" refers to the instruction and special care required in the used of the product to avoid undesired effects and to ensure the safe and effective use of the drug. 1.13. "Date of manufacture" for products other than biological products means the date (month and year) during which processing of the bulk product, from which the goods are to be filled, is completed. 1.14. "Batch number" refers to any distinctive combination of letters and/or numbers, assigned to a particular batch herein defined as any product produced during a given cycle of manufacture. The batch number permits the production history of the batch including all stages of manufacture and control, to be traced and reviewed. 1.15. "Lot number" refers to any distinctive combinations of letters and/or numbers assigned to a particular lot, herein defined as a portion of a batch. 1.16. "Expiration" or "expiry date" refers to the date after which the product is not expected to retain its claimed safety, efficacy and quality or potency or after which it is not permissible to sell, distribute or use said product. 1.17. "Net Content" refers to the total amount/quantity/number of the dosage form in a certain container of a product expressed in metric system. 1.18. "Storage condition" refers to the prevailing specified range temperature, humidity and other environmental factors within which optimal stability of the product is ensured based on laboratory data. 1.19. "Principal display panel" refers to the part of a label that is most likely to be displayed, presented, shown or examined under customary condition of display for retail use. 1.20. "Area of the principal display panel" refers to the area or surface of the container/package where the principal display panel is located.

1.21."Primary pack" is the first pack containing the individually wrapped products, strip blister packs. Section 2. General Requirements 2.1 The minimum mandatory information that shall be included in the labelling materials are: 2.1.1 Name of the product (Generic name alone or with Brand name, as the case may be) 2.1.2 Dosage form and strength 2.1.3 Pharmacologic category 2.1.4 Rx symbol, in case of prescription drugs 2.1.5 Name and complete address of manufacturer and trader, when applicable 2.1.6 Net content 2.1.7 Formulation 2.1.8 Indication(s) 2.1.9 Contraindication(s), precaution(s), warning(s) 2.1.10 Mode of administration/directions for use 2.1.11 Batch and lot number 2.1.12 Expiry/ expiration date and date of manufacture 2.1.13 Registration number 2.1.14 Storage conditions 2.1.15. (For Rx products) Foods, drugs and devices and Cosmetic Act prohibits dispensing without prescription 2.2. All information required to appear on the label must be: 2.2.1 Written in English or Filipino 2.2.2 Clearly and prominently displayed 2.2.3 Readable with normal vision without straining. The color contrast, the position and spacing of the information must be taken into consideration in complying with labelling requirements. 2.3. The principal display panel must: 2.3.1 Contain the particulars required under 2.1.1 to 2.1.6 2.3.2. Comprise 40% of the total surface of the container, except in the case of the rectangular container where the total area of the principal display panel must equal to the product of the height and width of the entire side of the container. For any other shaped container presenting an obvious principal display panel such as the top of a triangular or circular container, the size of the area shall consist of the entire top surface. 2.4 On the label of the immediate container outside of the principal display panel will appear the following information: 2.4.1.Formulation 2.4.2.Indication(s) 2.4.3.Mode of administration/directions (s) for use 2.4.4.Batch and lot number 2.4.5.Expiry/ expiration date and date of manufacture 2.4.6.Registration number 2.4.7.Storage conditions 2.4.8.(For Rx) Foods, Drugs and devices and Cosmetic Act prohibits dispensing

without prescription 2.5. Other information and additional detail shall appear on the other labelling materials such as inserts/leaflets or wrapper cartons. Section 3. Specific Requirements 3.1. Name of the product 3.1.1. In all cases, the generic name shall be the prominently printed element on the label, defined as the one with the highest point size among the various printed elements on the label. It shall be enclosed exclusively by an outline box rendered in the same color as the generic name. The background color inside the box, against with the generic name is rendered, should be the same color as the background color outside the box, against which the brand name is rendered. 3.1.2. In all cases, the generic name shall be printed in full, not abbreviated and in accordance with the International Non-proprietary Name (INN). In case the salt or the specific chemical form of the drug needs to be indicated, this must be included inside the box but in smaller point size. 3.1.3. If a product is identified by a brand name together with its generic name, the following shall be required in addition to 3.1.1 and 3.1.2. 3.1.3.1 The generic name and brand name shall be rendered using the same typeface, font and color, with the generic name appearing immediately above the brand name and rendered in a point size bigger than the brand name 3.1.3.2 If a brand name is presented using a special typeface exclusively designed and used for it, the generic name shall be rendered in Helvetica Medium or Universe Medium while complying with the other pertinent provisions above. 3.1.4. Products containing two active ingredients shall have the generic name of both active ingredients indicated within the box for generic name. 3.1.5. For products containing three or more active ingredients an official name for the combination, which shall serve as the equivalent of the generic name, shall be designated by a BFAD committee of experts. The starting date for the use of this official name on the label shall be in accordance with a schedule to be determine by BFAD. 3.2. Dosage form shall be specified such as tablets, capsules, syrups, suspensions, ointments, including special delivery system such as sustained release, etc. 3.3 Pharmacologic category shall conform to the category used in the Philippine National Drug Formulary attached as Annex "A" provided that drugs which cannot be classified under this categories may be given a therapeutic category other than what appears in the Annex subject to the approval of BFAD taking into consideration current acceptable standards for therapeutic categories. 3.4. Rx symbol 3.4.1. The Rx symbol must be printed in a contrasting color to the background on which it appears.

3.4.2. Over printing or superimposition of the Rx symbol is allowed provided that such will not result in obliterating or rendering less legible the other required label requirements. 3.4.3. The Rx symbol should be printed in a type size no less than one fifth (1/5) of the height of the principal displayed panel. 3.5. Complete name and address of manufacturer and also trader, when applicable, must appear on the principal display panel of the label. 3.6. Net content shall indicate the total amount/quantity/number of the dosage form in a given container of the product expressed in metric system. 3.7. Formulation 3.7.1. Active ingredient(s) must be stated in their generic names (INN). 3.7.2. The amounts of the active ingredient(s) shall be expressed in the metric system or unit of potency, when applicable, as specified in the official compendia. 3.7.3. The salt or chemical form(s) of active ingredient(s) must be stated, when applicable. 3.7.4. Multiple components must be enumerated in the order of decreasing pharmacologic activity, when applicable. 3.7.5. The coloring agent and other excipients used in the formulation that may cause hypersensitivity and/or other adverse reaction(s) must be indicated. 3.7.6. The alcohol content when present must be expressed in percent (%). 3.8. Indication shall state only the approved clinical use(s) of the product as stated in the approved BFAD registration. 3.9 Contraindication(s), Precaution(s), Warning(s) 3.9.1. Full information regarding contraindication(s) to the use of drugs, as well as precaution(s) to be observed in its administration and use must be provided. 3.9.2 Warning statements, as required, and specified by BFAD, must be stated. ANNOTATION: The BFAD may prescribe certain labelling information to be indicated on the label of certain drug products. One of this instances is the information required to be printed of the label of isopropyl alcohol 70% or preparations using isopropyl alcohol. On May 28, 1985 BFAD has required that preparations using isoprophyl alcohol must be indicated on its label the following additional information:

1) "For use in the hospital or sickroom as a rundown or for general massage purposes. This compound made from isopropyl alcohol does not contain nor is it offered as a substitute for ethyl or grain alcohol." 2) "FLAMMABLE." 3) "WARNING: For External Use Only." (To be printed in red color) and also, "Keep out of reach of Children."

Specific labelling requirements for specific products may come in the form of a Memorandum Circular which one may find in the chapter 6 of Banned or Restricted Drugs or Products. 3.10. Mode of Administration/Directions for Use 3.10.1. Full information must be provided for the recommended dosage, including the initial dose, the optimal use or usual dose, frequency interval, the duration of treatment, dosage adjustment or other pertinent aspects of drug therapy. 3.10.2. Relevant information regarding dilution, reconstitution, preparation and administration must be included. 3.10.3. Separate directions for adults and children, must be stated, and if not recommended for the children, the dosage shall be clearly identified as "adult dose". 3.11. Batch/Lot Number 3.11.1. If the entire batch is marketed under one company, only the batch number needs to be indicated. If however, a batch is divided into several lots are marketed by different companies, the lot number and its corresponding batch number shall be indicated for every lot. 3.11.2. The batch and/or lot number must be printed on each strip of ten (10) blister units. 3.12. Expiry/Expiration Date 3.12.1. The expiry or expiration date shall be expressed in terms of the month and the year. In such cases, the last day of the month is assumed as the expiration date. 3.12.2. For a drug that is reconstituted prior to use, a period of guaranteed efficacy must be specified at a given storage condition. 3.12.3. The expiration date shall be printed or embossed on the tin foil, blister and/or strip package. 3.13. Registration number shall indicate the drug registration number and code assigned by BFAD. 3.14. Storage conditions appropriate for the product must be stated. Section 4. Biological Products For biological products, the label must include, in addition to the requirements of Section 2 and 3: 4.1. The name and proportion of any antimicrobial agent in the product. 4.2. The name of any adjuvant in the product or any substance which, when administered with an antigen, modifies the immune response to that antigen. 4.3. The name of the species of animal or organism from which the product has been prepared.

4.4. For monoclonal antisera, the name of the species source or name of the species of origin of the hybridoma cell line used in the preparation of the product. 4.5. For viral vaccines produced in animal cells or cell cultures, the name of the cell culture substrate, or the name of the species of animal and tissue used in the manufacture of the product, as well as the name of any residual antibiotic present in the product, when applicable. 4.6. The potency of biological products which needs to be prepared before use, shall be expressed as potency unit or weight of active substances per dose. 4.7. The potency unit to be used shall be the International Unit has been established, the potency unit to be used shall be that approved by the BFAD taking into consideration current acceptable standards. 4.8. Date of manufacture which pertains to the date (month and year) of the latest quality control analysis performed on the product provided the product has been stored under conditions which have been shown to preserve the potency of the product. Section 5. Injections In addition to the requirements referred to in Section 2 and 3, when the product is a injection, the label shall include: 5.1. The name and quantity of all excipients in the product except where Section 6 applies. 5.2. A statement of the recommended routes of administration such as "intravenous", "intramascular", or "subcutaneous". 5.3. Where an antimicrobial agent is not included in the product, the words "Use only once or discard any remaining portion" or words to that effect. 5.4. Where the contents of the container are to be used on one occasion only, the words "single use" or "single dose". 5.5. Where the products consist of a concentrated solution for injection, a direction not to administer the solution undiluted and a direction to dilute the solution with the specified diluent to the appropriate volume before use. Section 6. Large Volume Injections In addition to the requirements referred to in Section 2 and 3, the label shall include: 6.1. The names and quantities of all excipients and active substances in the nominal volume of fluid in the container, listed in descending order of magnitude within each group of chemically similar substances. 6.2. Where one or more substances are amino acids and/or protein, a statement of the total amount of nitrogen in the nominal volume of fluid in the container. 6.3. The nominal osmolality. 6.4. A statement which specifies whether the solution is nominally "hypotonic" or "hypertonic". 6.5. The nominal pH range of the solution.

6.6. The words "single use" or "single dose". Section 7. Topical Products In addition to the requirements referred to in Section 2, and 3, the label shall include the name and proportion of any antimicrobial agent present in the product. Section 8. Products for External Use In addition to the requirements referred to in Section 2 and 3, the statement "FOR EXTERNAL USE ONLY" printed in red color must appear on the principal display panel of the label. Section 9. Small Containers Where the product is enclosed in a container which has a capacity of 10 milliliters or less and the container is enclosed in a primary pack. 9.1. The label of the container must contain the requirement of 2.1.1, company logo, strength, mode of administration, batch number and expiry date. 9.2. The label of the primary pack or other labelling materials must contain the requirements referred to in Section 2 and 3, and Section 4 and 5, when applicable. 9.3. When it is not practicable to set out particulars in full on a label on the container, the particulars referred to in 9.1 may be abbreviated, provided the abbreviation is not ambiguous. Section 10. Individually Wrapped Products, Strip and Blister Packs Where the product consist of individual dosage units, and each after which each individuals dosage unit is enclosed in primary pack: 10.1. The individual wrapper unit must contain the requirements of 2.1.1, company name or logo, strength and expiry date. 10.2. For products contained in strip or blister packs, the requirements of 2.1.1, strength, and expiry date must appear for every two units, and company name and batch number for every strip of 10 units. 10.3. The primary pack or other labelling materials must contain the requirements referred to in Section 2 and 3. Section 11. Exemptions 11.1. There a container or primary pack containing products is enclosed in a transparent covering and the particulars which are required to be set out on the label on the container or primary pack are clearly visible through the transparent covering. 11.2. Where products are made up or compounded by a pharmacist in a accordance with the individual prescription of a medicinal practitioner, dentist, or veterinarian. 11.3. Where products are used solely for investigational purpose. 11.4. Where products are donated by foreign agencies/ person, the requirements of generic labelling may be waived except that the expiry date must be indicated.

The requirements of this Regulation do not apply in relation to goods under 11.3, 11.4 and in exceptional cases where the labelling provisions of this Regulation are not appropriate, but in this cases exemption must be applied for and approved by BFAD on a case to case basis. ANNOTATION: The condition under which exemption from generic labelling may be granted are applicable to all, whether the labels are governed by A.O. 55 s. 88, A.O. 85 s. 90 or A.O. 99 s.90

Section 12. Violative/Prohibited Acts 12.1. Any product that is not labelled in accordance with the requirements of this Regulation shall be deemed misbranded. 12.2. The following acts and the causing thereof are hereby prohibited: 12.2.1. The manufacture, sale, offering for sale or transfer of any product that is misbranded. 12.2.2. Forging, counterfeiting, simulating or falsely representing or using any mark, stamp, label or other identification device required under the Regulation without proper authority. 12.2.3. The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labelling of product, if such act is done while such product is held for sale and results in such article being misbranded. 12.2.4. The use on the labelling of any product of any representation or suggestion that an indication with respect to such product is approved by BFAD or that such product complies with the provisions of this Regulation, when in fact it does not. 12.2.5. The use, in labelling of product of any reference to any BFAD report or documents (analysis) without clearance from BFAD. Section 13. Sanctions For violation of this Regulation, any or all of the following sanctions after due notice and summary hearing may be imposed by the Secretary of Health. 13.1. Suspension or revocation of the LTO of drug establishments and outlets and cancellation of Certificate of Product Registration. 13.2. Imposition of administrative fines of not less than P1,000.00 nor more than P5,000.00. 13.3. Recall from the market of misbranded products(s). 13.4. Confiscation of the violative(s). Section 14. Criminal Liability The imposition of the above sanctions does not preclude the institution of appropriate criminal proceedings pursuant to Section 26 of R.A No. 3720, as amended, and Section 12 of R.A No. 6675.

Section 15. Separability In case any provision to this rules and regulations is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect. Section 16. Repealing Clause All administrative Orders, Rules and Regulations and other administrative issuances or parts thereof, inconsistent with the provisions of this Regulation, are hereby repealed and modified accordingly. Section 17. Effectivity This regulation shall take effect fifteen (15) calendar days after publication in two newspapers of general circulation or in the Official Gazette. Provided, however, (1) that all productions shall be covered by these rules and Regulations as soon as the manufacturer or trader is ready but not later than April 1, 1989 except for multiple component products as provided for in 3.1.5; (2) that drug establishments shall have their new label approved by BFAD starting on the date of the effectivity of these rules and regulations, provided further, that all drug establishments shall report to BFAD the first batch number of their production which carries the new label. However, those product already in the market bearing the old labels on the date of effectivity of this Administrative Order shall be allowed to remain in the market but not later than December 31, 1989.

(Sgd) ALFREDO R.A. BENGZON Secretary

ANNOTATION: Drugstores or drug outlets and drug distributors are warned that sale, offer for sale and distribution of drugs not complying with the requirements of Generic Labelling shall be punishable. (Ref.: Memorandum Circular No. 1 s. 1990 dated 2.12.90)